Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations 10985 

1As set forth in a memorandum of understanding 

entered into by the HHS, the Food and Drug 

Administration (FDA), and the National Institute on 

Drug Abuse (NIDA), the FDA acts as the lead agency 

within the HHS in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1995. In 

addition, because the Secretary of the HHS has 

delegated to the Assistant Secretary for Health of 

the HHS the authority to make domestic drug 

scheduling recommendations, for purposes of this 

document, all subsequent references to ‘‘Secretary’’ 

have been replaced with ‘‘Assistant Secretary.’’ 

(2) Turkeys— 

Zoalene in grams/ton Combination in 

grams per ton Indications for use Limitations Sponsor 

(i) 113.5 to 170.3 ..... ................................. Growing turkeys: For prevention and control of coccidiosis.Feed continuously as sole ration. For turkeys grown for meat purposes only. Do 

not feed to laying birds.

054771 

(ii) 113.5 to 170.3 .... Bacitracin methylene 

disalicylate 4 to 50.

Growing turkeys: For prevention and control of coccidiosis; and for increased 

rate of weight gain and improved feed 

efficiency.

Feed continuously as sole ration until 14 

to 16 weeks of age. For turkeys grown 

for meat purposes only. Do not feed to 

laying birds.

054771 

Dated: February 3, 2014. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2014–02617 Filed 2–26–14; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–370] 

Schedules of Controlled Substances: 

Placement of Alfaxalone into Schedule 

IV 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Administrator of the Drug 

Enforcement Administration (DEA) 

places the substance 5a-pregnan-3a-ol11,20-dione (alfaxalone), including its 

salts, isomers, and salts of isomers, into 

schedule IV of the Controlled 

Substances Act (CSA). This scheduling 

action is pursuant to the CSA which 

requires that such actions be made on 

the record after opportunity for a 

hearing through formal rulemaking. 

This action imposes the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule IV controlled substances on 

persons who handle (manufacture, 

distribute, dispense, import, export, 

engage in research, conduct 

instructional activities with, or possess) 

or propose to handle alfaxalone and 

substances containing alfaxalone. 

DATES: Effective Date: March 31, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Ruth A. Carter, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The DEA implements and enforces 

titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, as amended. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, and are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purpose of this action. 21 U.S.C. 801– 

971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), parts 1300 to 1321. 

The CSA and its implementing 

regulations are designed to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

providing for the legitimate medical, 

scientific, research, and industrial needs 

of the United States. Controlled 

substances have the potential for abuse 

and dependence and are controlled to 

protect the public health and safety. 

Under the CSA, controlled substances 

are classified into one of five schedules 

based upon their potential for abuse, 

their currently accepted medical use, 

and the degree of dependence the 

substance may cause. 21 U.S.C. 812. The 

initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c), and the 

current list of all scheduled substances 

is published at 21 CFR part 1308. 

Pursuant to 21 U.S.C. 811(a)(1), the 

Attorney General may, by rule, ‘‘add to 

such a schedule or transfer between 

such schedules any drug or other 

substance if he (A) finds that such drug 

or other substance has a potential for 

abuse, and (B) makes with respect to 

such drug or other substance the 

findings prescribed by [21 U.S.C. 812(b)] 

for the schedule in which such drug is 

to be placed . . ..’’ Pursuant to 28 CFR 

0.100(b), the Attorney General has 

delegated this scheduling authority to 

the Administrator of the DEA. 28 CFR 

0.104. 

The CSA provides that scheduling of 

any drug or other substance may be 

initiated by the Attorney General (1) on 

his own motion; (2) at the request of the 

Secretary of the Department of Health 

and Human Services (HHS),1 or (3) on 

the petition of any interested party. 21 

U.S.C. 811(a). This action is based on a 

recommendation from the Assistant 

Secretary of the HHS and on an 

evaluation of all other relevant data by 

the DEA. This action imposes the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to schedule IV controlled substances on 

persons who handle or propose to 

handle alfaxalone. 

Background 

Alfaxalone (5a-pregnan-3a-ol-11,20- 

dione, previously spelled 

‘‘alphaxalone’’), a substance with 

central nervous system (CNS) 

depressant properties, is a neurosteroid 

that is a derivative of 11-alpha-hydroxyprogesterone. On October 23, 2012, the 

Food and Drug Administration (FDA) 

published a final rule to approve a New 

Animal Drug Application (NADA, 141– 

342) for alfaxalone (Alfaxan®), as an 

intravenous injectable anesthetic, for the 

induction and maintenance of 

anesthesia and for induction of 

anesthesia followed by maintenance of 

anesthesia with an inhalant anesthetic, 

in cats and dogs (77 FR 64715). 

Alfaxalone primarily acts as an agonist 

at the gamma-aminobutyric acid 

(GABA) receptor-channel complex, with 

a mechanism of action at this site 

similar to that of barbiturates like 

phenobarbital (schedule IV) and 

methohexital (schedule IV), 

benzodiazepines such as diazepam 

(schedule IV) and midazolam (schedule 

IV), as well as the anesthetic agents 


TKELLEY on DSK3SPTVN1PROD with RULES
10986 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations 

propofol (proposed to be controlled as a 

schedule IV substance, 75 FR 66195, 

Oct. 27, 2010) and fospropofol (schedule 

IV). 

HHS and DEA Eight-Factor Analyses 

On July 17, 2012, the Assistant 

Secretary of the HHS provided to the 

DEA a scientific and medical evaluation 

and scheduling recommendation 

entitled ‘‘Basis for the Recommendation 

to Control Alfaxalone in Schedule IV of 

the Controlled Substances Act.’’ After 

considering the eight factors in 21 

U.S.C. 811(c), including consideration 

of the substance’s abuse potential, 

legitimate medical use, and dependence 

liability, the Assistant Secretary of the 

HHS recommended that alfaxalone be 

controlled in schedule IV of the CSA 

under 21 U.S.C. 812(b). In response, the 

DEA conducted its own eight-factor 

analysis of alfaxalone pursuant to 21 

U.S.C. 811(c). Both the DEA and HHS 

analyses are available in their entirety in 

the public docket for this rule (Docket 

Number DEA–370) at 

www.regulations.gov under ‘‘Supporting 

and Related Material.’’ 

Determination to Schedule Alfaxalone 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation from the HHS, the 

Administrator of the DEA published in 

the Federal Register a notice of 

proposed rulemaking (NPRM) entitled 

‘‘Schedules of Controlled Substances: 

Placement of Alfaxalone into Schedule 

IV’’ which proposed placement of 

alfaxalone in schedule IV of the CSA. 78 

FR 17895, March 25, 2013. The 

proposed rule provided an opportunity 

for interested persons to file a request 

for hearing in accordance with DEA 

regulations by April 24, 2013. No 

requests for such a hearing were 

received by the DEA. The NPRM also 

provided an opportunity for interested 

persons to submit written comments on 

the proposal on or before April 24, 2013. 

Comments Received 

The DEA received four comments on 

the proposed rule to schedule 

alfaxalone. Two commenters were in 

favor of controlling alfaxalone as a 

schedule IV controlled substance. One 

commenter was in favor of controlling 

alfaxalone as a schedule V controlled 

substance rather than a schedule IV 

controlled substance, and one 

commenter opposed the control of 

alfaxalone. 

Support of the Proposed Rule: 

Two commenters supported 

controlling alfaxalone as a schedule IV 

controlled substance. These commenters 

indicated support for controlling 

alfaxalone under the CSA based on the 

abuse potential of the substance. 

Because alfaxalone is indicated for use 

as a pre-anesthetic and anesthetic in 

cats and dogs, these commenters felt 

that the abuse potential was particularly 

high for persons with access to the 

substance in the medical field. One 

commenter noted that controlling 

alfaxalone as a schedule IV controlled 

substance is appropriate because it 

could be abused in a manner similar to 

other schedule IV CNS depressants. The 

commenters believe that controlling 

alfaxalone as a schedule IV controlled 

substance will provide the necessary 

controls to prevent its diversion. 

DEA Response: The DEA appreciates 

the comments in support of this 

rulemaking. 

Opposition to the Proposed Rule: 

Two commenters opposed the 

proposal to control alfaxalone as a 

schedule IV controlled substance. 

Request Not to Control Alfaxalone: 

One commenter opposed controlling 

alfaxalone at all and stated that 

alfaxalone does not have the same abuse 

potential as Xanax® (alprazolam) 

(schedule IV), Valium® (diazepam) 

(schedule IV), and other 

benzodiazepines. The commenter also 

stated that controlling alfaxalone under 

the CSA would make it difficult for 

veterinarians and animal surgeons to 

acquire the drug. Lastly, this commenter 

stated that alfaxalone is ‘‘unheard of 

outside of the veterinary community 

and does not have a ‘black market’ as do 

the other schedule IV drugs.’’ 

DEA Response: The DEA does not 

agree. Pursuant to 21 U.S.C. 811(a)(1), 

the Attorney General may, by rule, ‘‘add 

to such a schedule or transfer between 

such schedules any drug or other 

substance if he (A) finds that such drug 

or other substance has a potential for 

abuse, and (B) makes with respect to 

such drug or other substance the 

findings prescribed by [21 U.S.C. 812(b)] 

for the schedule in which such drug is 

to be placed * * *.’’ This scheduling 

action was initiated when the DEA 

received a scientific and medical 

evaluation and a scheduling 

recommendation to control alfaxalone 

as a schedule IV controlled substance 

from the Assistant Secretary of the HHS. 

In accordance with 21 U.S.C. 811(c), the 

DEA conducted its own analysis of the 

eight factors determinative of control or 

removal: (1) Its actual or relative 

potential for abuse; (2) scientific 

evidence of its pharmacological effect, if 

known; (3) the state of current scientific 

knowledge regarding the drug or other 

substance; (4) its history and current 

pattern of abuse; (5) the scope, duration, 

and significant of abuse; (6) what, if any, 

risk there is to the public health; (7) its 

psychic or physiological dependence 

liability; and (8) whether the substance 

is an immediate precursor of a 

substance already controlled. The 

summary of each factor as analyzed by 

the HHS and the DEA, and as 

considered by the DEA in this 

scheduling action, was provided in the 

proposed rule. Both the DEA and the 

HHS analyses have been made available 

in their entirety under ‘‘Supporting and 

Related Material’’ of the public docket 

for this rule at www.regulations.gov 

under Docket Number DEA–370. 

Based on the review of the HHS 

evaluation and scheduling 

recommendation and all other relevant 

data, the DEA found that alfaxalone has 

an abuse potential similar to other 

schedule IV drugs, including the 

benzodiazepines diazepam and 

midazolam, the barbiturates 

phenobarbital and methohexital, and 

also the anesthetic agents propofol 

(proposed to be controlled as a schedule 

IV substance, 75 FR 66195, Oct. 27, 

2010) and fospropofol. Alfaxalone also 

acts as an agonist at the gammaaminobutyric acid (GABA) receptorchannel complex, with a mechanism of 

action at the site similar to that of 

benzodiazepines like 

diazepam(schedule IV) and midazolam 

(schedule IV). This mechanism of action 

is also similar to that of other schedule 

IV controlled substances, including 

barbiturates like phenobarbital and 

methohexital, and also anesthetic agents 

like propofol (proposed to be controlled 

as a schedule IV substance, 75 FR 

66195, Oct. 27, 2010) and fospropofol. It 

should be noted that alfaxalone’s 

current exclusive use as a veterinary 

anesthetic drug and the asserted 

conclusion that there is no ‘‘black 

market’’ for the substance, do not negate 

its abuse potential and associated risk of 

diversion. The DEA and HHS analyses 

demonstrate that alfaxalone does have 

the potential for abuse and meets the 

necessary findings on potential for 

abuse, currently accepted medical use, 

and physical or psychological 

dependence for placement in schedule 

IV. 

Burdens associated with acquiring a 

substance as a result of control under 

the CSA are not relevant factors to the 

determination whether a substance 

should be controlled or under what 

schedule a substance should be placed 

if it is controlled. See 21 U.S.C. 811 and 

812. Nonetheless, the DEA disagrees 

with the unsupported statement that 

making alfaxalone a controlled 

substance would make it difficult for 

veterinarians and animal surgeons to 


TKELLEY on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations 10987 

acquire the drug. Several other 

anesthetic substances used by 

veterinarians and other practitioners are 

controlled under the CSA. All 

veterinarians and animal surgeons who 

are authorized by the State in which 

they practice to handle alfaxalone and 

who are registered with the DEA to 

dispense controlled substances may 

acquire alfaxalone once it is controlled. 

As discussed in the Regulatory 

Flexibility Analysis section of this 

document, currently 98% of DEA 

registrants (most of which are small 

businesses) are already authorized to 

handle schedule IV controlled 

substances. 

Request to Control Alfaxalone as a 

Schedule V Substance: 

One commenter stated that alfaxalone 

should be controlled as a schedule V 

controlled substance. This commenter 

stated that there was limited 

information available regarding 

alfaxalone’s abuse. The commenter also 

stated that alfaxalone is a new 

introduction to the United States 

veterinary market, and controlling it in 

the least stringent schedule, schedule V, 

would minimize burdens on 

practitioners using it for legitimate 

purposes, while also imposing controls 

to account for its abuse potential. 

DEA Response: The DEA does not 

agree. The DEA thoroughly reviewed the 

scientific and medical evaluation and 

the scheduling recommendation to 

control alfaxalone as a schedule IV 

controlled substance from the HHS. 

Additionally, the DEA conducted its 

own analysis of the eight factors in 

accordance with 21 U.S.C. 811(b) and 

made the findings required under 21 

U.S.C. 812(b) for the placement of 

alfaxalone in schedule IV. Based on the 

review of the HHS’s evaluation and 

scheduling recommendation and all 

other relevant and available data, the 

DEA found that alfaxalone has an abuse 

potential similar to other schedule IV 

controlled substances, including the 

benzodiazepines diazepam and 

midazolam, barbiturates phenobarbital 

and methohexital, and also the 

anesthetic agents propofol (proposed to 

be controlled as a schedule IV 

substance, 75 FR 66195, Oct. 27, 2010) 

and fospropofol. 

While not relevant to the substance’s 

schedule placement, the DEA does not 

agree with this commenter’s concern 

that the requirements applicable to 

schedule IV controlled substances are 

more burdensome than the requirements 

applicable to schedule V controlled 

substances. There are only very minimal 

differences in handling requirements 

between schedule IV and schedule V 

controlled substances. Most importantly 

for purposes of responding to this 

comment, the physical security 

requirements for schedule IV and V 

controlled substances are the same. 

Also, under the CSA, schedule V 

controlled substances may be dispensed 

without a prescription, while schedule 

IV controlled substances may only be 

dispensed pursuant to a prescription. 

However, this distinction is of no 

consequence with regard to alfaxalone 

because alfaxalone cannot be prescribed 

by a veterinarian, nor may alfaxalone be 

dispensed by a pharmacist pursuant to 

a prescription. Federal law restricts this 

drug to use by or on the order of a 

licensed veterinarian (i.e., it may only 

be administered). 21 CFR 522.52; see 

also 21 CFR 514.8. 

Scheduling Conclusion 

Based on consideration of all 

comments, the scientific and medical 

evaluation and accompanying 

recommendation of the HHS, and based 

on the DEA’s consideration of its own 

eight-factor analysis, the DEA finds that 

these facts and all other relevant data 

constitute substantial evidence of 

potential for abuse of alfaxalone. As 

such, the DEA is scheduling alfaxalone 

as a controlled substance under the 

CSA. 

Determination of Appropriate Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

outlines the findings required for 

placing a drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analysis and 

recommendation of the Assistant 

Secretary for Health of the HHS and 

review of all available data, the 

Administrator of the DEA, pursuant to 

21 U.S.C. 812(b)(4), finds that: 

(1) 5a-pregnan-3a-ol-11,20-dione 

(alfaxalone) has a low potential for 

abuse relative to the drugs or other 

substances in schedule III; the overall 

abuse potential of alfaxalone is 

comparable to the schedule IV 

controlled substances diazepam, 

midazolam, phenobarbital, 

methohexital, propofol (proposed to be 

controlled as a schedule IV substance, 

75 FR 66195, Oct. 27, 2010), and 

fospropofol; 

(2) 5a-pregnan-3a-ol-11,20-dione 

(alfaxalone) has a currently accepted 

medical use in treatment in the United 

States; alfaxalone was approved for 

marketing by the FDA as a veterinary 

anesthetic product for the induction and 

maintenance of anesthesia in cats and in 

dogs; and 

(3) Abuse of 5a-pregnan-3a-ol-11,20- 

dione (alfaxalone) may lead to limited 

physical dependence or psychological 

dependence relative to the drugs or 

other substances in schedule III. 

Based on these findings, the 

Administrator of the DEA concludes 

that alfaxalone, including its salts, 

isomers, and salts of isomers, warrants 

control in schedule IV of the CSA. 21 

U.S.C. 812(b)(4). 

Requirements for Handling Alfaxalone 

Upon the effective date of this final 

rule, any person who handles alfaxalone 

is subject to the CSA’s schedule IV 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, 

dispensing, importing, exporting, 

engagement in research, and conduct of 

instructional activities, of schedule IV 

controlled substances including the 

following: 

Registration. Any person who handles 

(manufactures, distributes, dispenses, 

imports, exports, engages in research, or 

conducts instructional activities with) 

alfaxalone, or who desires to handle 

alfaxalone, must be registered with the 

DEA to conduct such activities, 

pursuant to 21 U.S.C. 822, 823, 957 and 

958, and in accordance with 21 CFR 

parts 1301 and 1312 as of March 31, 

2014. Any person who currently 

handles alfaxalone and is not registered 

with the DEA must submit an 

application for registration and may not 

continue to handle alfaxalone as of 

March 31, 2014 unless the DEA has 

approved that application, pursuant to 

21 U.S.C. 822, 823, 957, and 958, and 

in accordance with 21 CFR parts 1301 

and 1312. 

Security. Alfaxalone is subject to 

schedule III–V security requirements 

and must be handled and stored 

pursuant to 21 U.S.C. 821, 823, and 

871(b) and in accordance with 21 CFR 

1301.71–1301.93, as of March 31, 2014. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of alfaxalone must comply with 21 

U.S.C. 825 and 958(e) and be in 

accordance with 21 CFR part 1302, as of 

March 31, 2014. 

Inventory. Every DEA registrant who 

possesses any quantity of alfaxalone on 

the effective date of this final rule must 

to take an inventory of all stocks of 

alfaxalone on hand as of March 31, 

2014, pursuant to 21 U.S.C. 827 and 

958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11(a) and 

(d). 

Any person who becomes registered 

with the DEA after March 31, 2014 must 

take an initial inventory of all stocks of 

controlled substances (including 

alfaxalone) on hand on the date the 

registrant first engages in the handling 


TKELLEY on DSK3SPTVN1PROD with RULES
10988 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations 

of controlled substances, pursuant to 21 

U.S.C. 827 and 958 and in accordance 

with 21 CFR 1304.03, 1304.04, and 

1304.11(a) and (b). 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all stocks of controlled substances 

(including alfaxalone) on hand every 

two years, pursuant to 21 U.S.C. 827 

and 958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11. 

Records. All DEA registrants must 

maintain records with respect to 

alfaxalone pursuant to 21 U.S.C. 827 

and 958, and in accordance with 21 CFR 

parts 1304, 1307, and 1312, as of March 

31, 2014. 

Prescriptions. The DEA recognizes 

that alfaxalone is currently only 

approved as an injectable anesthetic that 

is administered to patients. The DEA 

also acknowledges that Federal law 

currently restricts alfaxalone to use by 

or on the order of a licensed 

veterinarian, and it may not be 

dispensed pursuant to a prescription. 21 

CFR 522.52; see also 21 CFR 514.8. A 

‘‘prescription’’ is defined as an order for 

medication which is dispensed to or for 

an ultimate user but does not include an 

order for medication which is dispensed 

for immediate administration to the 

ultimate user (e.g., an order to dispense 

a drug to a bed patient for immediate 

administration in a hospital is not a 

prescription). 21 CFR 1300.01(b). 

However, any lawful prescriptions for 

alfaxalone or prescriptions for products 

containing alfaxalone must comply with 

21 U.S.C. 829 and must be issued in 

accordance with 21 CFR parts 1306 and 

1311 subpart C as of March 31, 2014. 

Importation and Exportation. All 

importation and exportation of 

alfaxalone must be in compliance with 

21 U.S.C. 952, 953, 957, and 958, and 

be in accordance with 21 CFR part 1312 

as of March 31, 2014. 

Criminal Liability. Any activity 

involving alfaxalone not authorized by, 

or in violation of, the CSA, occurring as 

of March 31, 2014 is unlawful, and may 

subject the person to administrative, 

civil, and/or criminal sanctions. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

In accordance with 21 U.S.C. 811(a), 

this scheduling action is subject to 

formal rulemaking procedures done ‘‘on 

the record after opportunity for a 

hearing,’’ which are conducted pursuant 

to the provisions of 5 U.S.C. 556 and 

557. The CSA sets forth the criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

pursuant to section 3(d)(1) of Executive 

Order 12866 and the principles 

reaffirmed in Executive Order 13563. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform to eliminate drafting 

errors and ambiguity, minimize 

litigation, provide a clear legal standard 

for affected conduct, and promote 

simplification and burden reduction. 

Executive Order 13132 

This rulemaking does not have 

federalism implications warranting the 

application of Executive Order 13132. 

The rule does not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175 

This rule does not have tribal 

implications warranting the application 

of Executive Order 13175. The rule does 

not have substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act 

(RFA) (5 U.S.C. 601–612), has reviewed 

this final rule and by approving it 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. 

The purpose of this final rule is to place 

alfaxalone, including its salts, isomers, 

and salts of isomers, into schedule IV of 

the CSA. By this final rule, alfaxalone 

will remain in schedule IV unless and 

until additional scheduling action is 

taken to either transfer it between the 

schedules or to remove it from the list 

of schedules. See 21 U.S.C. 811 and 812. 

No less restrictive measures (i.e., no 

control or control in schedule V) enable 

the DEA to meet its statutory obligations 

under the CSA. 

On September 6, 2012, the FDA 

approved for use in the United States 

one product containing alfaxalone, 

which will have FDA marketing 

exclusivity and patent protection for 

several years. Accordingly, the number 

of currently identifiable manufacturers, 

distributors, importers, and exporters 

for alfaxalone is extremely small. The 

manufacturer who obtained FDA 

approval for the sale of alfaxalone 

product in the United States is not 

considered a ‘‘small entity’’ in 

accordance with the RFA and Small 

Business Administration (SBA) size 

standards. Upon expiration of the 

exclusivity period, and more likely, the 

related patent, additional products 

containing alfaxalone may receive 

approvals from the FDA, and thus 

additional manufacturers, distributors, 

importers, and exporters will handle 

alfaxalone. Whether such 

manufacturers, distributors, importers, 

or exporters may qualify as small 

entities cannot be determined at this 

time. 

There are currently approximately 1.5 

million controlled substance 

registrations, representing 

approximately 381,000 entities. The 

DEA estimates that 371,000 (97%) of 

these entities are considered ‘‘small 

entities’’ in accordance with the RFA 

and SBA size standards. 5 U.S.C. 601(6) 

and 15 U.S.C. 632. Due to the wide 

variety of unidentifiable and 

unquantifiable variables that potentially 

could influence the dispensing rates of 

new chemical entities, the DEA is 

unable to determine the number of 

small entities which might handle 

alfaxalone. However, because alfaxalone 

is a new chemical entity that is a 

veterinary anesthetic administered in 

veterinary settings and is not prescribed 

to ultimate users, the number of entities 

affected by the rule would be far fewer 

than the 381,000 entities represented by 

all DEA registrants. There are 

approximately 66,361 veterinarian 

practitioners and 23 veterinarian 

distributors (schedules III–V) registered 

with the DEA. 

Despite the fact that the number of 

small entities possibly impacted by this 

rule could not be determined, the DEA 

concludes that they would not 

experience a significant economic 

impact as a result of this rule. The DEA 

estimates all anticipated alfaxalone 

handlers to be DEA registrants, and 

currently 98% of DEA registrants (most 

of which are small entities) are 

authorized to handle schedule IV 

controlled substances. Even assuming 

that all of these registrants were to 

handle alfaxalone (e.g., practitioners 

administer the substance), the costs that 

they would incur as a result of 

alfaxalone’s scheduling would be 

nominal. 

Registrants that dispense (e.g., 

administer) alfaxalone are expected to 

incur nominal additional security, 

inventory, and recordkeeping costs. 

These registered entities have already 

established and implemented the 

systems and processes required to 

handle schedule IV controlled 


TKELLEY on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations 10989 

substances and can easily absorb the 

costs of administering alfaxalone with 

nominal to no additional economic 

burden. For example, because DEAveterinary practitioners are likely to 

already be schedule IV handlers, they 

already secure schedule II–V controlled 

substances in a securely locked, 

substantially constructed cabinet. See 

21 CFR 1301.75(b). Accordingly, the 

requirement to secure all controlled 

substances containing alfaxalone would 

not impose a significant economic 

burden upon DEA-registered 

practitioners as the infrastructure and 

materials for doing so are already in 

place. Labeling their products is routine 

and in the normal course of business of 

manufacturers. The DEA therefore 

assumes that the cost of compliance 

with 21 CFR part 1302 as a result of this 

final rule is nominal. Correspondingly, 

the DEA estimates that the cost of the 

labeling and packaging requirements of 

this final rule is nominal for the 

authorized manufacturer. Accordingly, 

compliance would not require 

significant additional manpower, capital 

investment, or recordkeeping burdens. 

Because of these facts, this rule will 

not result in a significant economic 

impact on a substantial number of small 

entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995 

(2 U.S.C. 1501 et seq.), the DEA has 

determined and certifies pursuant to 

UMRA that this action would not result 

in any Federal mandate that may result 

‘‘in the expenditure by State, local, and 

tribal governments, in the aggregate, or 

by the private sector, of $100,000,000 or 

more (adjusted for inflation) in any one 

year * * * .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under provisions of 

UMRA of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995. 44 U.S.C. 3501–3521. This action 

would not impose recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act (CRA). This rule will not 

result in: an annual effect on the 

economy of $100,000,000 or more; a 

major increase in costs or prices for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. However, pursuant to 

the CRA, the DEA has submitted a copy 

of this final rule to both Houses of 

Congress and to the Comptroller 

General. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, 21 CFR 

part 1308 is amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 2. Amend § 1308.14 by redesignating 

paragraphs (c)(1) through (c)(53) as 

paragraphs (c)(2) through (c)(54) and 

adding new paragraph (c)(1) to read as 

follows: 

§ 1308.14 Schedule IV. 

* * * * * 

(c) * * * 

(1) Alfaxalone—(2731) 

* * * * * 

Dated: February 21, 2014. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2014–04332 Filed 2–26–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Office of the Attorney General 

28 CFR Parts 50 and 59 

[Docket No. 145; AG Order No. 3420–2014] 

Policy Regarding Obtaining 

Information From, or Records of, 

Members of the News Media; and 

Regarding Questioning, Arresting, or 

Charging Members of the News Media 

AGENCY: Office of the Attorney General, 

Department of Justice. 

ACTION: Final rule. 

SUMMARY: This rule amends the policy 

of the Department of Justice regarding 

the use of subpoenas, certain court 

orders, and search warrants, to obtain 

information from, or records of, 

members of the news media. The rule 

also amends the Department’s policy 

regarding questioning, arresting, or 

charging members of the news media. 

DATES: This rule is effective on February 

27, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Monique Roth, Director, Office of 

Enforcement Operations, Criminal 

Division, (202) 514–6809. 

SUPPLEMENTARY INFORMATION: 

Discussion 

In May of 2013, the Department 

initiated a comprehensive evaluation of 

its practices and policies regarding the 

use of subpoenas, court orders, and 

search warrants to obtain information 

from, or records of, members of the 

news media. As part of this process, the 

Department convened a series of 

meetings to solicit input from a wide 

range of news media stakeholders, First 

Amendment academics and advocates, 

and Members of Congress. Based on this 

review, the Department issued a report 

on July 12, 2013, announcing changes to 

the Department’s policies. 

This final rule revises the existing 

provisions in the Department’s 

regulations at 28 CFR 50.10. The 

revisions are intended to ensure that, in 

determining whether to seek 

information from, or records of, 

members of the news media, the 

Department strikes the proper balance 

among several vital interests: (1) 

Protecting national security, (2) 

ensuring public safety, (3) promoting 

effective law enforcement and the fair 

administration of justice, and (4) 

safeguarding the essential role of the 

free press in fostering government 

accountability and an open society. 

The revisions also ensure more robust 

oversight by senior Department officials; 

centralize the internal review and 

evaluation process; set out specific 

standards for the use and handling of 

information obtained from, or records 

of, members of the news media; and 

extend the policies to cover the use of 

subpoenas, court orders issued pursuant 

to 18 U.S.C. 2703(d) and 3123, and 

search warrants. 

The changes to the policy also 

strengthen the presumption that 

Department attorneys will negotiate 

with, and provide advance notice to, 

affected members of the news media 

when investigators seek to obtain from 

third parties communications records or 


TKELLEY on DSK3SPTVN1PROD with RULES